Recruiting

Oxygenation Strategies

Sponsor:

Frederic T Billings IV

Code:

NCT07224243

Conditions

Surgeries Undergoing General Anesthesia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lower FiO2

Intermediate FiO2

Higher FiO2

Study Details

Brief summary:

This multicenter, cluster-randomized, cluster-crossover clinical trial evaluates the impact of three intraoperative FiO2 (Fraction of Inspired Oxygen) oxygenation strategies-lower (FiO₂ 0.21-0.40), intermediate (FiO₂ 0.40-0.80), and higher (FiO₂ 0.80-1.00)-on postoperative organ injury and mortality in adult surgical patients. The trial aims to determine the optimal oxygenation strategy to improve perioperative outcomes.

Conditions

Surgeries Undergoing General Anesthesia

Study ID

NCT07224243

Start date

Dec 1, 2025

Status verified date

Jun, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient located in a participating operating room
  • Planned surgery includes tracheal intubation

Exclusion Criteria:

  • Patient is known to be less than 18 years old
  • Patient is known to be pregnant
  • Patient is known to be a prisoner.
  • Patient is American Society of Anesthesiologists (ASA) classification-6 (i.e., organ donor)
  • Patient's planned surgical case includes open heart surgery, defined as surgery on the heart or ascending aorta requiring sternotomy or thoracotomy.
  • Patient's planned procedure requires prolonged apnea, bronchoscopy, airway surgery, or one-lung ventilation.
  • Patient's planned surgical case includes use of extracorporeal membrane oxygenation (ECMO).
  • Patient is known to have a history of bleomycin treatment.
  • Patient was enrolled in the trial in the prior 30 days.

Study Design

Enrollment

54000 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lower FiO2

experimental: Intermediate FiO2

experimental: Higher FiO2

Interventions

Lower FiO2

FiO₂ 0.21-0.40 or lowest FiO₂ to maintain SpO₂ ≥ 94% during maintenance anesthesia

Intermediate FiO2

FiO₂ 0.40-0.80 or lowest FiO₂ to maintain SpO₂ ≥ 94% during maintenance anesthesia

Higher FiO2

FiO₂ > 0.80 to maintain SpO₂ ≥ 94% during maintenance anesthesia

Primary outcome measure

  • Composite of organ injury or in-hospital death within 30 days of surgery [ Time Frame: 30 days post-surgery ]

Central Contacts and Locations

Central contacts

Tracie Baker, CCRA

6158751852tracie.d.baker@vumc.org

Locations

Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68105

Contacts

Emely Sanchez, BS

402-559-8299emsanchezrodriguez@unmc.edu

Principal Investigator:

Levi Zehr, MD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37212

Contacts

Tracie Baker, CCRA

6158751852tracie.d.baker@vumc.org

Principal Investigator:

Meredith Kingeter, MD

University of Utah Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Anne Mackey, MD

801-580-6886Anne.mackey@utah.edu

Principal Investigator:

Caroline Ruminski, MD

More Information

Sponsor

Frederic T Billings IV

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Keywords

  • Intraoperative oxygenation
  • oxygen
  • surgery
  • anesthesia
  • mechanical ventilation
  • organ injury
  • acute kidney injury
  • myocardial injury
  • lung injury
  • stroke
  • pragmatic
  • cluster

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Frederic T Billings IV on 2026-06-10.